FDA Approves Injectable Form of Ibuprofen

[Justin]

This injectable form of ibuprofen, Caldolor, will be available for hospital use only. Nonetheless, I found this news release interesting.


FDA NEWS RELEASE

For Immediate Release: June 11, 2009
Media Inquiries: Karen Riley, 301-796-4674; karen.riley @ fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn.

Link

[KBear]

very interesting, thanks for sharing. I don't know how you do all this research, go to school and run this forum, all while recovery from major surgery. You are amazing, thanks

[Gilbert P]

Hi Dr J

Yea bring it on

Thanks

Gilbert P

[Justin]

very interesting, thanks for sharing. I don't know how you do all this research, go to school and run this forum, all while recovery from major surgery. You are amazing, thanks

Thanks Kathy. I'm not back at school for awhile, so I am working on the rest of the website here and there trying to get it done. It would have been done a couple weeks ago, but I ran into a few hiccups. I really enjoy being on the forum support others--I'm not the type of person to just sit around and relax. I always have to be doing something productive. My wife says my work ethic is a curse.

Hi Dr J

Yea bring it on

Thanks

Gilbert P

Thanks Gil...I'll try and post some more interesting topics when I see them.